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Aquestive Therapeutics Rolling NDA for Libervant

[ Price : $8.95]

Aquestive Therapeutics completes a rolling NDA submission for Libervant (diazepam) Buccal Film for managing seizure clusters.

Electronic Format Transparency Needed: Comment

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AdvaMed urges FDA to be transparent and flexible in developing plans for regulatory submissions in electronic format.

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company American Contract Systems.

House Hearing to Grill FDA on Foreign Inspections

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The House Energy and Commerce Oversight and Investigations Subcommittee plans a 12/10 hearing to question FDA on its foreign drug ...

AnazaoHealth FDA-483

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FDA releases an FDA-483 with three observations issued following an inspection at AnazaoHealth.

Mullin Reelected ICH Management Committee Chair

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The International Council on Harmonization reelects FDAer Theresa Mullin to a one-year term as chair of its management committee.

QS Violations Found at American Contract Systems

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FDA warns American Contract Systems about Quality System violations in its work manufacturing medical devices and acting as a cont...

Review Period for Amgens Aimovig

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Amgens Aimovig (erenumab-ao...

Hahns FDA Nomination Heads to Full Senate

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Senate Health, Education, Labor & Pensions Committee votes 18 to 5 to advance Stephen Hahns nomination to serve as FDA commissione...

Guide on Drug Trial Adaptive Designs

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Federal Register notice: FDA makes available a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics...